Herbs consumed as teas have been reported to cause diarrhea and hematologic, cardiac and gastrointestinal effects [ 40 ]. Herbal products from Asia have been reported to be problematic since it contains numerous contaminants. Quality control of herbal drugs and their formulations is of vital importance in order to justifying their acceptability in modern system of medicine.
A major concern facing the herbal drug market is the unavailability of the source and quality of herbal materials and their formulations [ 42 ]. Other factors such as the temperature, use of fresh plants, light exposure, nutrients, water availability, period and time of harvest, method of harvesting, drying, packing, storage and transportation of raw herbal material, etc. Some plant elements are heat labile and the plants containing them need to be dried at low temperatures [ 11 ].
Herbal remedies can be sold as supplements, for supporting, maintaining, stimulating and promoting health in many countries. These supplements require a label that defines the ingredients are intended to affect the functions within humans in line with Act of and amendments [ 14 ]. The evidence on the efficacy, safety and quality of such herbal products is unknown, therefore, raising a concern on the safety of these herbal medicines [ 8 ]. The concern surrounding safety of herbal medicinal products is increasing [ 8 ].
In order to allay these concerns and achieve public reliance on herbal medicine, manufacturers, researchers and regulatory authorities must follow inclusive clinical trials and vigorous scientific methodologies to ensure the quality and safety of herbal products [ 41 ]. The safety evaluation of any herbal drug considers two important factors; the nature and significance of the adversarial effect. Toxicity screening can disclose some of the risks related to the use of herbal medicine [ 43 ].
In , WHO issued guidelines for the assessment of herbal medicine which include: i Quality assessment: crude plant material; plant preparation; finished product. A national policy on herbal medicine may include the following: a defining role of herbal medicine in the health care system, provision for the necessary regulations and laws, contemplation of intellectual property concerns [ 22 ].
National policies vary from country to country regarding herbal medicine. Herbal medicines are classified as either prescription or non-prescription medicines. The Working Party on Natural and Nutritional Supplements was established by the Australian Parliament to evaluate the safety, efficacy, quality and labeling of herbal products Therapeutic Good Act, In accordance to these regulations, a product license is required for all herbal products to be sold in Canada.
The recommended use, potency, comprehensive information on the medicinal constituents, source and nonmedicinal constituents need to be provided in order for a license to be granted. The companies that manufacture, pack, label and import herbal medicine also need a site license [ 3 ]. The Dietary Supplement Health and Education Act DSHEA of , states that any herb, natural and botanical concentrate, constituent and metabolite of extract, is categorized as a dietary supplement.
These supplementations do not need any sanction from the FDA. Herbal medicine which is categorized as dietary supplements under DSHEA, are alleged to be safe and the FDA does not have the authority to require them to be approved for efficacy and safety before they enter the market. However, manufacturers of these herbal products are required to provide purity and identification standards, and confirm that claims made concerning their products are precise [ 39 , 44 ].
In Chile the Unidad de Medicina Tradicional was established in , with the aim of incorporating herbal medicine with established efficacy into health programs Law No. Directive No. Registration for marketing authorization is required for herbal products.
These products are lawfully distinguished as follows: 1 drugs intended to alleviate, cure or prevent disease; 2 food products with therapeutic properties and for medicinal use, and 3 food products with nutritious purposes [ 11 ]. The guidelines state that for herbal medicine to be released in the market, it needs authorization from the national regulatory authorities of each country in Europe and the herbal products must have a standard level of efficacy and safety.
The registration of herbal products from outside the European Union EU require substantial evidence of their medicinal use, at most a period of 15 years within EU and 15 years elsewhere [ 3 ]. In Germany, more than monographs on medicinal plants have been regulatory evaluated, and in France more than herbs have been recorded as acceptable ingredients of herbal medicine [ 4 ].
The widespread use of herbal medicine in Brazil is favored by two present public policies i. Currently, herbal medicines are registered in Brazil, of these are single medicines and the other 25 are composed of more than one medicinal plant [ 45 ].
Herbal medicine has gained increasing popularity in the last two decades in industrialized countries. This was formed to interest scientists in the field of medicinal plants [ 3 ]. According to the NIH survey, 4 out of 10 adults In , the European Scientific Cooperative on Phytotherapy was formed with an aim to advance herbal medicine [ 3 ]. These scientific evaluations have led to an upsurge in the investment of herbal medicine [ 3 ].
In the past decade, about pharmaceutical products have been formulated based on herbal medicine knowledge [ 42 ]. Because of the increase in the acceptance of plant derived drugs, the use of plants in medicine as a source of therapeutic agents will expand rapidly in the future [ 42 ].
This has extremely increased international trade of herbal medicine, attracting a number of pharmaceutical companies, including the multinationals [ 11 ].
The interest of WHO by documenting the use of medicinal plants used by ethnic groups, has increased scientific validation of the use of these plants. This will make people better informed concerning the effectiveness and safety of the treatment [ 21 ]. The regulation of herbs has assisted in improving herbal products, however additional changes need to be applied to advance and indorse high quality research [ 10 ].
The use of herbal medicine is not restricted to developing countries. Over the years, there has been an escalating interest in the use of herbal medicine worldwide. This has greatly expanded the demand for plant products, since herbal medicine has an advantage of being inexpensive with minimal side effects compared to synthetic medicines. The growth of the herbal drug market has attracted pharmaceutical companies which in turn have driven scientific validation and clinical studies on herbal medicines.
Thus far, few programs have been established to study the safety and efficacy of herbal medicines as originally proposed by the WHO Guidelines for the assessment of herbal medicines. These guidelines have been helpful in establishing the role of herbal medicine in the health care industry.
However, the data to provide a precise assessment on the safety, quality and efficacy of herbal medicine is inadequate generating concerns regarding the use of herbal products. Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution 3. Help us write another book on this subject and reach those readers. Login to your personal dashboard for more detailed statistics on your publications. Edited by Philip Builders. Edited by Arup Bhattacharya. We are IntechOpen, the world's leading publisher of Open Access books.
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Throughout much of history, humans believed that the "vital spirit" of the plant contributed to its therapeutic effect. But in the early s, scientists isolated morphine from opium, which led to the belief in the West at least that a single, non-living compound in a plant was responsible for its healing properties.
This, in turn, helped create the biomedical model of pharmacotherapy that still remains in medicine today. In this model, plants are seen simply as the source of a single chemical that targets a single receptor site or other part of the body and fixes the individual's health problem, much as a mechanic might use a wrench to fix an automobile.
This "machine" model of living systems can be useful, but it is clearly inadequate to explain the complexity of the human system. Humans display properties that are not reducible to the component parts, unlike parts of a machine.
Likewise, the healing effects of plants cannot always be reduced to a single element. Eventually most scientists believed that there was no need to use plants themselves in drugs because chemists could synthesize compounds that were more potent and often more toxic than the natural products offered by nature.
Now, most pharmaceuticals are synthetic compounds. But note that the structure of synthetic pharmaceuticals often resembles natural molecules.
And as prominent botantical researcher Joanne Raskin noted in her study, 11 percent of the drugs considered essential by the World Health Organization are exclusively derived from flowering plants. Viewing plant medicines as simply sources of chemical compounds instead of vital spirits had profound political, economic, and scientific impacts.
Once the therapeutic effects of plants were attributed to inert chemicals, certain medical practitioners, who increasingly wanted to portray their profession as a rational and scientific endeavor, sought to distance themselves from the "superstitious" and intuitive practices of herbalists and other traditional healers.
In the United States, the teaching of herbalism in the curricula of medical schools was prohibited and whole schools were closed in the s. One of the casualties was the University of Minnesota's school of homeopathic medicine, which was closed as a result of these reforms.
The s witnessed a swing back toward a more holistic perspective in medicine, with less reliance on potent drugs that often have serious side effects. This change contributed to a renewed interest in botanical medicines that generally have fewer risks than pharmaceutical drugs. DSHEA allowed botanical medicines to be sold as "dietary supplements" as long as the manufacturers didn't make any health claims.
Note that this provision can be somewhat confusing and puts the burden on consumers to research the dietary supplements themselves. In , the Federal Drug Administration FDA announced a final rule establishing current good manufacturing practice requirements for dietary supplements.
The final rule requires manufacturers to report all adverse events to the FDA, as well as evaluate the identity, purity, quality, strength, and composition of its dietary supplements. This change places more accountability on the industry and should increase consumers' confidence in the quality of dietary supplements, according to the FDA.
Between and , the use of botanical medicines increased by percent in the United States. Outside the United States, the World Health Organization reports that 75 to 85 percent of the world's population continues to rely on botanical medicines dispensed by traditional healers for primary healthcare, as they have always done.
Scientists have renewed efforts to study botanicals, resulting in increasing scientific evidence for the safety and efficacy of many botanical medicines, especially for chronic diseases and health maintenance.
In addition, schools of pharmacy and medicine have revived courses in science-based herbalism and pharmacognosy.
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